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ONIVYDE irinotecan (as sucrosofate) 43 mg/10 mL nanoliposomal concentrated injection for infusion, Ervier Laboratories (Aust) Pty Ltd, CON-1248
Product name
ONIVYDE irinotecan (as sucrosofate) 43 mg/10 mL nanoliposomal concentrated injection for infusion
Sponsor name
Ervier Laboratories (Aust) Pty Ltd
Batches
Lot 001231, Lot 001825 and Lot 004892
Consent start
Consent no.
CON-1248
Duration
The consent is effective from 14 June 2024 until 31 March 2025.
Standard
Paragraph 8(1)(l) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not have the instructions for preparation, storage conditions
or the maximum storage period on the label or as a package insert.
Conditions imposed
A ‘Dear Healthcare Provider’ letter identical to that provided to the TGA on 14
June 2024 will be supplied with each affected batch providing details of the
missing information and weblinks to where it can be found.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines